Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers >12 cm2 to ≤ 36 cm2

Completed · Phase 3

Conditions studied: Venous Leg Ulcers

In brief

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA). At least 250 subjects will participate. The study is going to be conducted in approximately 50 sites in the United States and Canada.

Key facts

Study ID

NCT01737762

Run by

Healthpoint

People needed

155

Starts

2012-11-01

Expected to finish

2015-11-01

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide informed consent.
• Age ≥ 18 years and of either sex.
• Willing to comply with protocol instructions, including allowing all study assessments.
• Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area >12 cm2 to ≤ 36 cm2
• Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
• Arterial supply adequacy confirmed
• Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
• Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
• Acceptable state of health and nutrition

You may not qualify if…

• History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
• Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
• Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
• A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
• Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
• Refusal of or inability to tolerate compression therapy.
• Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
• History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
• Any prior exposure to HP802-247 or its vehicle.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Carlsbad, California, United States
• Study site — Castro Valley, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Fresno, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Sylmar, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Jacksonville, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Saginaw, Michigan, United States
• Study site — Washington, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Bayonne, New Jersey, United States

Full record on ClinicalTrials.gov

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